Depression Can Shift the Rhythm. Research Is Looking to Restore It.

Depression from bipolar 1 disorder can change the rhythm of everyday life, making familiar routines and connections harder to maintain.
The [PROGRAM NAME] Program is evaluating an investigational treatment for adults experiencing
depression from bipolar 1 disorder. Learn more.

You may be able to participate in the Kalea Trial if you:

Are 18–70 years old

Have been diagnosed with MDD

and are currently in a depressive episode with moderate to severe symptoms lasting at least 1 month to no more than 2 years

Have tried at least 1 oral (by mouth) antidepressant treatment for a prior or current major depressive episode

If you are interested in participating, the trial doctor or staff will review additional trial criteria with you.

Participants will receive all trial-related treatments (investigational product or placebo) and trial-related care at no cost, and they may be reimbursed for trial-related travel and expenses.

About the Kalea Trial

The Kalea Trial is evaluating the effectiveness and safety of an investigational product for adults with MDD who are currently in a depressive episode with moderate to severe symptoms lasting at least 1 month to no more than 2 years, have previously had at least 1 depressive episode, and have tried at least 1 oral (by mouth) antidepressant for a prior or current major depressive episode.

During the double-blind treatment period, participants will be randomly assigned to 1 of 2 groups to receive either the investigational treatment or a placebo (a substance that looks like the investigational treatment but contains no active ingredients), both given as injections. “Double-blind” means that neither you nor the trial doctor or staff will know which treatment you are receiving. Eligible participants may also take part in an open-label treatment period, during which all participants will receive the investigational treatment.

Throughout the trial, participants will have scheduled visits at the trial clinic for health exams and tests. They will also have up to 2 telehealth visits with the trial doctor/staff. Between trial visits, they will not have to record data nor take investigational product at home.

Total participation will include up to 10 trial visits over the course of approximately 28 weeks. Some visits will take place virtually.

© 2026 Clinical Trial Media. All Rights Reserved. The images depicted contain models and are being used for illustrative purposes only.